Especially in the pharmaceutical/biopharmaceutical industry, but also in the chemical and food industry, demands are increasing on the safe handling of powdered materials that are used and to be produced. On the one hand, employees are to be protected as much as possible from any influence by the product. On the other hand, the product is to be protected from any influence by the employee.
Split valves, as for example found in EP 1 083 137 A1, are increasingly being used with great success for the critical system part, that is, the docking site of mobile containers made of high-grade steel in the processing units also made of high-grade steel. This technology allows the containers to be docked almost completely contamination-free at the processing unit. Subsequently, the product is safely added, and the container is likewise undocked contamination-free from the processing unit.
However, an increasing need for the use of disposable containers is presently discernible. The reason for this need is the industrial approach of using these systems to produce different products for cost reasons, and not just to produce a single product. In this context, the issue of cross-contamination increasingly arises. Despite thoroughly cleaning of the containers and the system, remaining traces of the previously produced product can contaminate the new products to be produced. Such cross-contamination can result in an entire production batch being useless and having to be destroyed, which can quickly reach a value of several hundred thousand euros.
By using disposable containers and optimally disposable liners as well in the processing units, this potential problem of cross-contamination can be entirely circumvented.
Furthermore, the use of such disposable components can improve the life cycle assessment of the system operator.
In the conventional cleaning of the systems, the cleaning media used must be completely discarded, for example by burning. The energy expended for cleaning and drying is enormous.
By omitting such cleaning when using disposable containers, the issue of cleaning is almost completely eliminated.
Disposable components must also be eliminated of by burning. However, this burning can be done expending significantly less energy given the considerably smaller volume. Furthermore, by using easily disposable materials such as PE, environmental considerations are again taken into account.
Flexible disposable components are, however, also subject to the same requirements that stainless steel components were previously. In this case as well, the docking, filling and undocking process must be designed to be contamination-free.
The subsequent response to this challenge can be found in disposable closure systems available on the market, such as in EP 1 441 953 81. The greatest flexibility in regard to possible uses with a simultaneously high cost/benefit ratio is arguably offered by profiled closure systems such as found in DE 10200400351 1 84, DE 10 2009 018 565 83 or EP 2 455 297 A1.
The systems having a divided slider that simultaneously opens the docked profiled closures, while docking had proven to be technically infeasible.
The disadvantage of the system with separate sliders that offers the best economical solution at present is that the complementary closures docked by the sliders are initially closed and must be opened in an additional manual step.
However, this additional step poses a large functional risk in practice since the closures can be entirely torn part if not correctly handled, which risk constitutes an unacceptable weak point in view of the intended use.
Furthermore, the profiled closures, which can be docked together by the sliders, have a hooked profile that extends into the product area when in a docked and open state, that is, in the state of product transfer, which is associated with two significant disadvantages.
On the one hand, finely powdered material can easily enter the hooked profile grooves and entirely compromise subsequent functioning.
On the other hand with this design, the material of the profile per se comes into contact with the product since the tubular film of the container can only be attached below the hooking profile, which requires an additional validation, that is, of the profile material, when used in the pharmaceutical industry.